Metabolic SyndromePhase 2ECoMNCT02117661

Carnitine for the Treatment of Atherosclerosis.

A Phase 2 study testing L-carnitine capsules and Cellulose capsules in people with Metabolic Syndrome, run by Dr. Amer Johri at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Metabolic Syndrome
What is being tested?: L-carnitine capsules and Cellulose capsules
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 177 participants
Where: 2 sitesCanada
Study dates: Jan 2015to May 2019
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

STEP 1: Initial screening; BP, weight and fasting blood samples will be obtained.
Men and women, >18 years, meeting the criteria for clinical diagnosis of MetS, according to the International Diabetes Federation (IDF) harmonized definition, where any 3 of the 5 following risk factors cut points constitutes a diagnosis of MetS:
Elevated waist circumference: Population- and country-specific definitions; Health Canada recommends males 102 cm and women 88cm.
Elevated triglycerides: 150 mg/dL (1.7 mmol/L).
Reduced HDL: 40 mg/dL (1.0 mmol/L) in males; 50 mg/dL (1.3 mmol/L) in females or treated.
Elevated BP: Systolic 130 and/or diastolic 85 mm Hg or treated.
Elevated fasting glucose: 100 mg/dL (5.6 mmol/L), or HbA1c ≥6.2%, or treated.
Willing to provide informed consent. STEP 2: Baseline plaque volume ≥50 mm3 by 3D US, to ensure sufficient detectable plaque. This will be measured after consent (at Step 1), but prior to randomization/enrolment (Step 2).

Who cannot join

Individuals who have had a change in statin and/or diabetes medication therapy or dosing in the last three months;
Who are actively having an unstable arrhythmia, angina or heart attack (untreated and/or unstable patients): symptomatic heart failure (NYHA 2 or greater); renal failure (GFR <50 mL/min/1.73m2);
Known severe abnormal blood biochemistries: Na <100 or >150 mmol/L, K <2 or >5 mmol/L, Total Serum Ca >3 mmol/L;
Known severe liver disease: AST >100 U/L, ALT >80 U/L, or a diagnosis of cirrhosis (Child Pugh Class A to C);
Known severe anemia: HgB <70 g/L;
Have endocrine disorders, e.g. Cushing's disease, hyper- or hypo-thyroidism;

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Any condition expected to limit survival to less than six (6) months (ex. malignant tumor);
A condition limiting adherence to study procedure (i.e. alcoholism, drug addiction, known poor adherence, severe mental disorder);
Concomitant treatment with: anticonvulsants; L-C or derivatives; Acenocoumarol (Sintrom) and Warfarin (Coumadin) anticoagulants and vitamin K antagonists; >1g fish oil; and/or thyroid treatment;
A seizure disorder or at risk of seizure (CNS mass or medications that lower seizure threshold); receiving treatments for cancer or HIV infection (secondary L-C deficiency);
Currently pregnant or breastfeeding;
A history of allergy or intolerance to L-C or derivatives;
Vegetarians (do not eat animal flesh) due to potential for altered L-C metabolism;
Patients who have had a carotid surgery (ie. endarterectomy (CEA) or stent) or who are scheduled to receive carotid surgery during the trial.

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

Queen's University, Cardiovascular Imaging Network at Queen's (CINQ), Kingston General Hospital
Kingston, Ontario, K7L 3N6
Robarts Institute, Stroke Prevention & Atherosclerosis Research Centre (SPARC)
London, Ontario, N6G 2V2

Other trials in Canada

About this study

Official title: ECoM Study: Effect of Carnitine Supplementation on Progression of Carotid Plaque in the Metabolic Syndrome.

Obesity is one of the main causes of the metabolic syndrome, a condition which is becoming more common in Canada and worldwide. Metabolic syndrome is a name for a group of heart disease risk factors that occur together: obesity, diabetes, high blood pressure, and high cholesterol. These patients have a high risk of developing narrowing and blockages of blood vessels which occur when fat and cholesterol build up in the walls of blood vessels and form plaque. This is called atherosclerosis. Plaque buildup leads to stroke, heart attacks, and death. We do not understand the underlying mechanisms of the metabolic syndrome and we do not have a treatment for it. L-carnitine, a dietary supplement, has been shown to treat some components of the metabolic syndrome, but its benefit to reduce plaque in the blood vessels has never been studied. Recently there has been some controversy because a new study showed that L-carnitine could make heart disease worse in some patients. Our goal is to study whether supplementation with L-carnitine does in fact prevent or reduce buildup of plaque in blood vessels of patients with the metabolic syndrome. This novel therapy has the potential to decrease the burden of heart disease in obese and diabetic patients with the metabolic syndrome.

Read the detailed description

Primary Question: Does L-carnitine (L-C) therapy slows down and/or regress atherosclerosis, as measured by total plaque volume (TPV) assessed by 3-dimensional (3D) carotid ultrasound in patients with metabolic syndrome? We hypothesize that L-C will regress atherosclerotic plaque formation.

To assess our primary outcome of L-C induced atherosclerosis regression, we anticipate a significant percent (%) difference in carotid total plaque volume (TPV) over six months of L-C treatment, compared to placebo. For our secondary outcome, we expect to show that L-C therapy compared to placebo, induces a reduction in the proportion of small-sized LDL and an increase in large LDL particles. As small dense LDL particles are more atherogenic than large buoyant ones, this would suggest a mechanism contributing to the atherosclerosis reduction induced by L-C therapy.

Conditions: Metabolic Syndrome
Being tested: L-carnitine capsules, Cellulose capsules
Keywords: L-carnitine, Metabolic syndrome, Atherosclerosis, Coronary artery disease, Carotid, Plaque, Cardiovascular disease, Heart disease, Vascular disease
Medical subject headings: Metabolic Syndrome, Atherosclerosis, Coronary Artery Disease, Plaque, Amyloid, Cardiovascular Diseases, Heart Diseases, Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

L-carnitine capsulesDietary supplement
Also called levocarnitine, carnitor
Oral
Cellulose capsulesDietary supplement
oral

Study groups in NCT02117661
Study group	Role	What they receive
L-carnitine capsules	Experimental	2000 mg daily (2x 500 mg capsules twice a day - BID) for six months Receives: Dietary Supplement: L-carnitine capsules
Cellulose capsules	Placebo comparator	2x capsules twice a day - BID (4 total per day) for six months Receives: Dietary Supplement: Cellulose capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in carotid Total Plaque Volume
Carotid 3D ultrasound scan
Measured: Six months

Secondary outcomes (1)

Change in LDL size profile
Blood test
Measured: Six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2015May 2019

First posted21 Apr 2014 (estimated)
Study startJan 2015
Primary completionJul 2017
Study completionMay 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 177 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02117661
Sponsor's protocol ID: L-Carnitine-01
Acronym: ECoM
Status last verified: Nov 2018
First submitted: 16 Apr 2014
Last updated: 26 Jun 2020
Results posted: No
Data monitoring committee: Yes

Publications

Johri AM, Hetu MF, Heyland DK, Herr JE, Korol J, Froese S, Norman PA, Day AG, Matangi MF, Michos ED, LaHaye SA, Saunders FW, Spence JD. Progression of atherosclerosis with carnitine supplementation: a randomized controlled trial in the metabolic syndrome. Nutr Metab (Lond). 2022 Apr 2;19(1):26. doi: 10.1186/s12986-022-00661-9.
PubMed 35366920

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Metabolic Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ECoM Study: Effect of Carnitine Supplementation on Progression of Carotid Plaque in the Metabolic Syndrome.
ClinicalTrials.gov ID: NCT02117661
Acronym / sponsor ID: ECoM / L-Carnitine-01
Conditions: Metabolic Syndrome
Keywords: L-carnitine, Metabolic syndrome, Atherosclerosis, Coronary artery disease, Carotid, Plaque, Cardiovascular disease, Heart disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 177 participants (actual)
Lead sponsor: Dr. Amer JohriUniversity, hospital or other
Collaborators: Heart and Stroke Foundation of Canada, Queen's University
Study start: Jan 2015 (actual)
Primary completion: Jul 2017 (actual)
Study completion: May 2019 (actual)
First posted: 21 Apr 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
L-carnitine capsules	Experimental	Dietary Supplement: L-carnitine capsules2000 mg daily (2x 500 mg capsules twice a day - BID) for six months
Cellulose capsules	Placebo comparator	Dietary Supplement: Cellulose capsules2x capsules twice a day - BID (4 total per day) for six months

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

STEP 1: Initial screening; BP, weight and fasting blood samples will be obtained.
Men and women, >18 years, meeting the criteria for clinical diagnosis of MetS, according to the International Diabetes Federation (IDF) harmonized definition, where any 3 of the 5 following risk factors cut points constitutes a diagnosis of MetS:
Willing to provide informed consent. STEP 2: Baseline plaque volume ≥50 mm3 by 3D US, to ensure sufficient detectable plaque. This will be measured after consent (at Step 1), but prior to randomization/enrolment (Step 2).

Key exclusion criteria (14 listed)

Individuals who have had a change in statin and/or diabetes medication therapy or dosing in the last three months;
Who are actively having an unstable arrhythmia, angina or heart attack (untreated and/or unstable patients): symptomatic heart failure (NYHA 2 or greater); renal failure (GFR <50 mL/min/1.73m2);
Known severe abnormal blood biochemistries: Na <100 or >150 mmol/L, K <2 or >5 mmol/L, Total Serum Ca >3 mmol/L;
Known severe liver disease: AST >100 U/L, ALT >80 U/L, or a diagnosis of cirrhosis (Child Pugh Class A to C);
Known severe anemia: HgB <70 g/L;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
L-carnitine capsulesAlso: levocarnitine, carnitorOral	Dietary supplement	L-carnitine capsules
Cellulose capsulesoral	Dietary supplement	Cellulose capsules

Primary outcome

Change in carotid Total Plaque Volume
Time frame: Six months
Carotid 3D ultrasound scan

1 secondary outcome

Change in LDL size profile
Time frame: Six months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2020.
Derived from this study: PubMed 35366920Johri AM, Hetu MF, Heyland DK, Herr JE, Korol J, Froese S, Norman PA, Day AG, Matangi MF, Michos ED, LaHaye SA, Saunders FW, Spence JD. Progression of atherosclerosis with carnitine supplementation: a randomized controlled trial in the metabolic syndrome. Nutr Metab (Lond). 2022 Apr 2;19(1):26. doi: 10.1186/s12986-022-00661-9.
Cardiovascular Imaging Network at Queen's (CINQ)Link provided by the sponsor.

Related trials for Metabolic Syndrome

RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Amer M Johri, MD principal investigator

Queen's University

J.David Spence, MD principal investigator

Robarts Institute

Daren K Heyland, MD principal investigator

Queen's University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing L-carnitine capsules and Cellulose capsules in people with Metabolic Syndrome, run by Dr. Amer Johri at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in carotid Total Plaque Volume (time frame: Six months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02117661, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2020.